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FDA 510(k)

ADVIA Centaur Calcitonin (CALCT) assay

K-Number: K182012 · 2018-12-21

ApplicantAxis-Shield Diagnostics Limited
Decision Date2018-12-21
Product CodeJKR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVIA Centaur Calcitonin (CALCT) assay is the device name listed in this FDA 510(k) record. The listed applicant is Axis-Shield Diagnostics Limited. It received FDA 510(k) clearance on 2018-12-21 under 510(k) number K182012. The device is classified under product code JKR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA Centaur Calcitonin (CALCT) assay?

ADVIA Centaur Calcitonin (CALCT) assay is a medical device that received FDA 510(k) clearance on 2018-12-21. The listed applicant is Axis-Shield Diagnostics Limited. The 510(k) number is K182012.

When did ADVIA Centaur Calcitonin (CALCT) assay receive FDA 510(k) clearance?

ADVIA Centaur Calcitonin (CALCT) assay received FDA 510(k) clearance on 2018-12-21, under 510(k) number K182012.

Who is the listed applicant for ADVIA Centaur Calcitonin (CALCT) assay?

The FDA 510(k) record lists Axis-Shield Diagnostics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVIA Centaur Calcitonin (CALCT) assay?

The FDA product code for ADVIA Centaur Calcitonin (CALCT) assay is JKR.

Other records listing Axis-Shield Diagnostics Limited as applicant

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K253539Alere NT-proBNP for Alinity iK241176Alere NT-proBNP for Alinity i Reagent KitK233541ARCHITECT Active-B12 (Holotranscobalamin)K183088ADVIA Centaur Erythropoietin (EPO) assayK172133ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayK153551ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.

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Related Devices (Code: JKR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252431Elecsys CalcitoninRoche Diagnostics GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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